Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorAjou University School of Medicine
About this trial
The goal of this clinical trial is to develop and evaluate youth-focused intervention programs for suicide and self-harm that are tailored to the psychological, developmental, and cultural characteristics of Korean adolescents and young adults. The study examines whether two structured, mindfulness-based intervention programs-one for middle and high school students and one for young adults-reduce suicidal ideation, self-harm behaviors, depressive symptoms, and emotion-regulation difficulties.
The study also aims to determine whether these clinical improvements are associated with biological changes, including alterations in resting-state functional brain activity (e.g., ALFF, ReHo, and functional connectivity) and social rhythm patterns.
The main questions this study seeks to answer are:
* Does the youth suicide and self-harm intervention program reduce suicidal ideation and self-injurious thoughts/behaviors? * Does the program improve mood, sleep, hopelessness, and emotion regulation? * Are improvements in clinical outcomes accompanied by changes in biological markers of suicide risk? * Researchers will compare the intervention program to usual care provided in hospitals, schools, and community mental health settings.
Participants will:
* Participate in the structured suicide/self-harm intervention program or receive usual care. * Complete standardized assessments of mood, sleep, emotion regulation and suicide/self-harm risk. * Undergo biological assessments, including resting-state fMRI and rhythm-related measures, at baseline and follow-up. * Be followed for up to 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
General Criteria
Aged between 15 and 30 years
Obtained informed consent from a parent or legal guardian for participants under 19 years of age
For the Self-Harm Group
Disqualifiers
Psychiatric and Developmental Conditions
History of developmental disorders, including intellectual disability or autism spectrum disorder
Diagnosis of schizophrenia or bipolar disorder
Currently in an acute psychotic state
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Harm Intervention and Education for Long-term Development (SHIELD) Program
BehavioralA structured, module-based psychological intervention program consisting of 8 weekly sessions. The program is tailored into three customized tracks based on the participant's age and clinical needs: * Common Core Module (Cross-cutting): Social Rhythm Therapy (SRT) is applied to all participants starting from Session 2 to stabilize daily routines (sleep, meals, activities) and reduce emotional impulsivity. * Track 1: Youth Self-Harm Program (Ages 14-18): Focuses on functional understanding of non-suicidal self-injury, mindfulness-based emotion regulation, interpersonal skills, and behavioral therapy. * Track 2: Youth Suicide Program (Ages 14-18): Includes an intensive behavioral therapy session (Session 3) for crisis analysis, followed by mindfulness, interpersonal skills, and cognitive therapy modules to enhance resilience and prevent suicide attempts. * Track 3: Young Adult Program (Ages 19-30): Addresses both self-harm and suicide-related issues through personalized modules inc
General Mental Health Education
BehavioralParticipants watch 8 educational videos over an 8-week period. The education is ideally conducted at the research site. Similar to the intervention group, participants are also required to use a wearable device during the study period.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Youth Suicide and Self-Harm Intervention ProgramExperimental treatment 1 intervention
Group B: General Mental Health Education ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Suicidality (DSI-SS Score)
The DSI-SS is a 4-item self-report questionnaire designed to assess the frequency and intensity of suicidal ideation and impulses. Scores range from 0 to 12, with higher scores indicating greater severity of suicidality; a score of 3 or higher is considered the clinical cut-off for high suicide risk.
Time frame
Baseline and Week 8, Baseline and Week 122
Change from Baseline in Functional Assessment of Self-Mutilation (FASM) Frequency Score
The FASM assesses the methods and frequency of non-suicidal self-injury (NSSI), as well as the functions maintaining the behavior. It distinguishes between Internal Functions (e.g., emotion regulation) and Social Functions (e.g., influencing others). The instrument yields data on the total frequency of self-mutilative behaviors and separate scores for these functional domains.
Time frame
Baseline and Week 8, Baseline and Week 123
Change from Baseline in Self-Harm Screening Inventory (SHSI) Total Score
The SHSI is a 10-item self-report measure used to screen for non-suicidal self-injury (NSSI) behaviors over the past year. It assesses 10 specific methods of self-harm (e.g., cutting, hitting, overdosing) performed without the intent to die. Each item is scored as 0 (No) or 1 (Yes). Total scores range from 0 to 10; a score of 1 or higher (indicating any experience of self-harm) is the cut-off for recommending a visit to a psychiatrist.
Time frame
Baseline and Week 8, Baseline and Week 124
Change from Baseline in Circadian rhythm stability
Circadian rhythm stability refers to the consistency of 24-hour rest-activity patterns across days, as assessed using wrist-worn actigraphy. Inter-daily Stability (IS) quantifies the degree of similarity between daily activity profiles across consecutive days, with values ranging from 0 to 1. Higher IS values indicate greater stability and synchronization of the circadian rest-activity rhythm.
Time frame
Through the end of the intervention period (approximately 12 weeks)Secondary outcomes
1
Change from Baseline in Barratt Impulsiveness Scale (BIS-II) Total Score
The BIS-II is a 23-item questionnaire designed to assess the personality construct of impulsiveness. Total scores range from 23 to 92, where higher scores indicate higher levels of impulsiveness.
Time frame
Baseline and Week 8, Baseline and Week 122
Change from Baseline in Difficulties in Emotional Regulation Scale-Short Form (DERS-SF) Total Score
The DERS-SF is an 18-item self-report measure used to assess difficulties in emotion regulation. Scores range from 18 to 90, where higher scores indicate greater difficulty in emotion regulation.
Time frame
Baseline and Week 8, Baseline and Week 123
Change from Baseline in Distress Tolerance Scale (DTS) Total Score
The DTS is a 15-item self-report measure of emotional distress tolerance. Scores range from 15 to 75, with higher scores indicating higher levels of distress tolerance (i.e., better capacity to withstand distress).
Time frame
Baseline and Week 8, Baseline and Week 124
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score
The GAD-7 is a 7-item instrument used to assess the severity of generalized anxiety. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Severity categories are defined as Mild (5-9), Moderate (10-14), and Severe (15-21). A total score of 10 or greater is the clinical cut-off for identifying probable generalized anxiety disorder.
Time frame
Baseline and Week 8, Baseline and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ajou University School of Medicine
Lead sponsor
Korea Health Industry Development Institute
Collaborator
Sungshin Women's University
Collaborator
Source ClinicalTrials.gov